Kornimate/medical-research-clean huggingface dataset:
studying malnutrition and sarcopenia in older adults with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Leukemia, Myeloid

Summary: this study will explore how malnutrition (poor nutrition/diet) and sarcopenia (a condition that causes a loss of muscle and bone mass) affects study participants over the age of 60 with acute myeloid leukemia (aml) who will receive induction chemotherapy (chemotherapy given as the first treatment to help cancer go into remission) and/or cancer drugs as part of standard care for aml. by studying how these nutritional and skeletal factors, doctors leading this study hope to learn how malnutrition and sarcopenia may be able to predict certain outcomes --such as how long study participants with poor nutrition and muscle loss can live after chemotherapy- for older (age 60+) individuals with aml.


Eligibility criteria:
inclusion criteria: * older adult patients (greater than or equal to 60 years of age) * new diagnosis of acute myeloid leukemia (aml) * receiving induction therapy (intensive or low intensity therapy) * willing and able to provide written informed consent exclusion criteria: * presence of a pacemaker or defibrillator. * participants who are pregnant at the time of enrollment. * anyone unable/unwilling to follow protocol requirements

Keywords: aml
the tranquility trial: clinical trial to assess the efficacy and safety in subjects with dry eye disease

Conditions: Dry Eye; Dry Eye Syndromes

Summary: the tranquility trial: multi-center randomized, double-masked, parallel design, vehicle-controlled phase 2/3 clinical trial to assess the efficacy and safety of 0.25% reproxalap ophthalmic solution compared to vehicle in subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: * 18 years of age (either gender and any race); * reported history of dry eye for at least 6 months prior to visit 1; * reported history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1 exclusion criteria: * clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * contact lens use within 7 days of visit 1 or anticipate using contact lenses during the trial; * eye drop use within 2 hours of visit 1; * previous laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of visit 1; * be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of visit 1 or anticipate such therapy throughout the study period; * planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; * temporary punctal plugs during the study that have not been stable within 30 days of visit 1

Keywords: reproxalap adx-102 tranquility
emollient therapy in preterm & low birth weight neonates: a randomized clinical trial

Conditions: Weight Gain

Summary: the objective of this study is to assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.

the study will be conducted at the department of pediatric medicine unit 1, kemu / mayo hospital lahore. total of 140 neonates fulfilling the eligibility criteria will be enrolled. they will be randomly divided into two groups - a and b. mothers of the neonates in group a will be advised massage with sunflower oil while mothers of the neonates in group b will be advised massage without any emollient. babies will closely be followed up and their weight and length will be measured at six months of age and will be analyzed using spss v 23.0.

Eligibility criteria:
inclusion criteria: * neonates of both genders * both breast fed and non-breast fed infants * neonates with birth weight between 1.5 and 2.5 kg * preterm neonates born between 28 and 37 completed weeks of gestation exclusion criteria: * neonates with genetic syndrome, infection or with a history of admission in nicu due to any reason will be excluded.

Keywords: emollient low birth weight preterm weight length.
preoperative prehabilitation in patients with head and neck cancer or liver cancer (prepare)

Conditions: Cancer Liver; Cancer Head Neck

Summary: the objective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with head and neck cancer or liver cancer. participating patients will participate in a 3-to-6 week rehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling.

in patients diagnosed with head and neck cancer (hnc) or liver cancer, (major) surgery is the standard of care. nevertheless, surgery may result in complications that have a substantial impact on the physical and psychological state of the patient. detrimental postoperative outcomes are influenced by unhealthy lifestyle behaviors such as a sedentary lifestyle, smoking and malnutrition. prehabilitation programs focusing on these lifestyle aspects have been suggested as a promising intervention to improve pre- and postoperative outcomes. therefore, the obective of this study is to determine the feasibility (main aim) and effectiveness (secondary aim) of a prehabilitation program in patients with hnc or liver cancer this study concerns a prospective cohort study in 60 patients with hnc or liver cancer that participate in a 3 to 6-week pilot prehabilitation program consisting of training and nutritional, smoking cessation and psychosocial counselling. data on feasibility (program satisfaction, program compliance and percentage of patients willing to participate in the prehabilitation program) and effectiveness (e.g. complications, health status, compliance to healthy lifestyle) is collected at three time points (pre- and post the prehabilitation program and 30 days post-surgery).

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of head and neck cancer or liver cancer * scheduled for surgery in erasmus mc * provision of written informed consent * only patient with a waiting time of at least 3 weeks till surgery can participate in this study exclusion criteria: * patients that do not understand the dutch language * patients with severe physical or psychological comorbidities that limit participation in the prehabilitation program
the effect of intravenous lidocaine on normal sensation and pain in healthy volunteers

Conditions: Pain

Summary: the purpose of this study is to study if lidocaine, given intravenously, reduces pain.

clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Eligibility criteria:
inclusion criteria: * healthy adult volunteers, age \>19 years exclusion criteria: * history of substance abuse * coronary artery disease (cad): unstable * congestive heart failure (chf): unstable * heart arrhythmia: symptomatic * chronic obstructive pulmonary disease (copd) * lidocaine allergy * diagnostic and statistical manual of mental disorders (rev iv): axis i: common axis i disorders include depression, anxiety disorders,bipolar disorder, adhd, and schizophrenia. axis ii: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation. * presence of contraindications for mri * presence of electronically, magnetically, and mechanically activated implants * electronically, magnetically, and mechanically activated implants * ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators * cardiac pacemakers * metallic splinters in the eye * ferromagnetic haemostatic clips in the central nervous system (cns) * claustrophobia * pregnancy

Keywords: lidocaine allodynia chronic regional pain syndrome pain
loneliness and health outcomes in the high need population

Conditions: Anxiety; Loneliness; Depression; Alcohol Use Disorder; Utilization, Health Care

Summary: the high need population are patients who have three or more chronic diseases and have a functional limitation in their ability to take care for themselves. investigators aim to understand the effects of a support group intervention, with the use of group medical visits and understand longitudinal effects in emotional wellbeing and loneliness.

the high need population with functional limitations are patients who have three or more chronic diseases and have a functional limitation in their ability to care for themselves (such as bathing or dressing) or perform routine daily tasks. two-thirds of the population is female, and three-quarters of them are white non-hispanic and half of the population were described as low income. the high need population with functional limitations also utilizes the emergency department at twice the rate of adults with multiple chronic diseases and more than three times more likely to be hospitalized than adults of other populations. loneliness is seen as a significant independent risk factor for poor health behaviors, physical health problems and psychiatric conditions. loneliness and isolation are becoming a more recognized entity that contributes to worsening depression. investigators aim to compare the of effects of a social worker and physician/app-led support group intervention on loneliness at 9 months, after up to 3 group visits. shared medical visits as a form of support group increase clinician-patient contact time and provide patients with support and prevention of chronic conditions increasing patient empowerment.

Eligibility criteria:
inclusion criteria: patients who are enrolled into the vic program. these are patients that are 18 years old and above, and have either * hcc score 3.0 and above * hcc 2.0 - 3.0 and 2 or more unplanned admissions in last 12 months * hcc 0.24 - 0.35 + esrd or * charlson score \>3, or lace \>30 exclusion criteria: * none

Keywords: high need population shared medical visits social determinants of health
single dose crossover study of patient preference for unscented nasonex® nasal spray versus scented flonase® nasal spray (study p04208)

Conditions: Allergic Rhinitis

Summary: this was a one-day single dose trial conducted to compare patient's preference for nasonex® (mometasone) versus flonase® nasal spray. each patient was randomized to take one dose (2 sprays in each nostril) of nasonex or flonase. thirty minutes later, each patient was to take one dose of the opposite medication. questionnaires were given to each patient after each drug dose to evaluate patient product preference.


Eligibility criteria:
inclusion criteria: * subject must have been 18-65 years of age, of either sex and any race. * subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of \ 2; congestion must have been \<2. * subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations. * subject must have understood and been able to adhere to the dosing and visit schedule. exclusion criteria: * subject had used any investigational product within 30 days prior to enrollment. * subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study. * subject was participating in any other clinical study(ies). * subject was using any nasal lavage fluid or spray. * subject was using any perfume during the study day. * subject was using any oral rinse during the study day. * subject had used topical or oral nasal decongestants in the past 1 week. * subject had used a nasal corticosteroid in the previous 2 weeks. * subject had anosmia or ageusia (absence of the sense of smell or taste). * subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing. * subject had a respiratory infection in the 2 weeks prior to testing.
text education about cardiovascular health and hiv (teach-hiv)

Conditions: HIV; Human Immunodeficiency Virus; Cardiovascular Diseases; Atherosclerosis

Summary: the overall objective is to evaluate the efficacy of educational text messages to reduce cardiovascular risk among persons living with hiv (plwh).


Eligibility criteria:
inclusion criteria: * hiv positive * at least 40 years of age * english-speaking exclusion criteria: * existing clinical atherosclerotic cardiovascular disease (ascvd) * pregnant * unwilling/unable to provide informed consent * does not own a smartphone
study of bladder cancer detection in standard white light versus ai-supported endoscopy-02

Conditions: Bladder Cancer

Summary: this study is being conducted to investigate if an artificial intelligence support tool is non-inferior in detecting bladder cancer compared to the traditional method, standard white light cystoscopy (wlc). the researchers will compare how well the artificial intelligence tool and wlc perform in detecting bladder cancer through a controlled, organized testing process.

this clinical investigation aims to confirm that an artificial intelligence model utilizing a convolutional neural network (cnn) can achieve sensitivity in detecting bladder cancer that is non-inferior to traditional white light cystoscopy (wlc) in a randomized controlled trial. the investigational artificial intelligence device leverages the advanced capabilities of cnns, a type of deep learning model designed to analyze visual imagery with high precision.

Eligibility criteria:
inclusion criteria: * men and women adults, age \>18 years old suspicion of primary or recurrent bladder cancer willingness to sign the informed consent form (icf) for the ci ability to comprehend the oral and written patient information leaflet (pil) exclusion criteria: * not able or willing to sign the informed consent form
the effect of the mediterranean diet on obstructive sleep apnoea-hypopnoea syndrome: a randomised trial

Conditions: Obstructive Sleep Apnoea; Hypopnoea Syndrome

Summary: this study aims to investigate the role of the mediterranean diet in obese patients with obstructive sleep apnoea-hypopnoea syndrome.

obstructive sleep apnoea-hypopnoea syndrome (osahs) is considered to be one of the most prevalent sleep-related breathing disorders, with an enormous effect on public health. approximately 2-4% of the general adult population experiences some degree of this syndrome. this percentage increases even more with obesity, up to 20-40%, especially in individuals with an excessive body mass index (bmi) \> 30 kg/m2. osahs is associated with significant systemic consequences, including cardiovascular morbidity and mortality, and the risk increases with the severity of the syndrome. the pathophysiology underlying the link between osahs and the cardiovascular system is attributed largely to systemic inflammation and oxidative stress, which are both contributors to endothelial dysfunction. the treatment modalities of osahs include continuous positive airway pressure (cpap), weight loss, upper airway surgery, and medication. cpap is the first line therapy, as a means of maintaining upper airway patency, and it is well known that this intervention reduces morbidity and mortality. in severe cases of osahs the weight loss strategy is essential and must accompany cpap treatment. a growing body of evidence in osahs supports the beneficial role of weight reduction, induced by diet alone or in combination with exercise, leading to a reduction in apnoeas and hypopnoeas.we aim to evaluate the effect of the mediterranean diet compared with that of a prudent diet on obese osahs patients who were treated with cpap while receiving counselling to increase their physical activity.

Eligibility criteria:
inclusion criteria: * patients with apnoea-hypopnoea index \>15/h and epworth sleepiness scale \> 10 exclusion criteria: * diseases such as ischaemic heart disease, diabetes mellitus, thyroid disorders, and malignancies * upper airway surgery * gestation * alcoholism * diet for weight reduction during the last 6 months * eating habits close to the mediterranean diet at the entry phase * intake of antioxidant supplements * medications affecting weight * smoking (in the case of tbars) * therapy with sleeping pills * use of anti-depressive medication * bmi \< 30.0 kg/m2

Keywords: obstructive sleep apnoea/hypopnoea syndrome mediterranean diet exercise weight loss continuous positive airway pressure lipid peroxidation
comparing telepsychiatry and in-person outcomes

Conditions: Psychiatric Disorders

Summary: psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes and be less costly when provided via videoconferencing (telepsychiatry) than when provided in-person.

we predict that patients referred by their family physician for a psychiatric consultation and, if needed, short-term follow-up will have equivalent clinical outcomes when seen via telepsychiatry as compared to those patients seen in-person. we also predicted that telepsychiatry will be cheaper than in-person care.study design: a single-centre equivalence trial.we will use a sample size calculation and analytical methods that are specifically tailored for equivalence trials.

Eligibility criteria:
inclusion criteria: * patients referred by their family physicians for psychiatric consultation * scores in the dysfunctional range on the brief symptom inventory exclusion criteria: * patients incapable of consenting to the research * patients referred for medico-legal or insurance reports

Keywords: telepsychiatry videoconference psychiatric consultation equivalence trial
apatinib for relapsed and refractory diffuse large b cell lymphoma

Conditions: Relapsed and Refractory; Diffuse Large B Cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of apatinib for patients with relapsed refractory diffuse large b cell lymphoma.

patients with relapsed /refractory diffuse large b cell lymphoma usually have a bad prognosis. these patients cannot be treated successfully with the conventional chemotherapy of chop. apatinib is a new type of oral tyrosine kinase inhibitor targeting vegfr-2.the investigators have been proceeding this trial to evaluate the efficacy and safety of apatinib in the patients with relapsed refractory diffuse large b cell lymphoma.

Eligibility criteria:
inclusion criteria: * age range 14-70 years old; ecog performance status 0-2. * estimated survival time \> 6 months. * histological confirmed diffuse large b cell lymphoma. * have taken first-line chemotherapy regimen and failed. * none of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/l, platelet ≥ 100×109/l, alt and ast ≤ 2×uln, serum bilirubin ≤ 1.5×uln, serum creatine ≤ 1.5×upper limitation of normal (uln), serum albumin ≥ 30g/l, serum plasminogen is normal. * at least one measurable lesion. * none of other serious diseases, cardiopulmonary function is normal. * pregnancy test of women at reproductive age must be negative. * patients could be followed up. * none of other relative treatments including the traditional chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent. exclusion criteria: * disagreement on blood sample collection. * patients allergic of any of drug in this regimen or with metabolic disorder. * pregnant or lactating women. * serious medical illness likely to interfere with participation. * serious infection. * primitive or secondary tumors of central nervous system. * chemotherapy or radiotherapy contraindication. * the evidence of cns metastasis. * history of peripheral nervous disorder or dysphrenia. * patients participating in other clinical trials. * patients taking other antitumor drugs. * patients estimated to be unsuitable by investigator.

Keywords: r r dlbcl orr pfs os
a study of first line treatment with tarceva (erlotinib) in combination with gemcitabine in patients with unresectable advanced and/or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: this single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. the anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * advanced and/or metastatic (stage iiib/iv) unresectable non-small cell lung cancer; * no previous systemic chemotherapy, radiation therapy or immunotherapy; * eastern cooperative oncology group (ecog) \>=2. exclusion criteria: * prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (her1/egfr) inhibitors; * active, non-controlled systemic disease; * any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
a study to investigate multiple ascending doses of azd5004 in healthy japanese participants and participants with type 2 diabetes mellitus

Conditions: Healthy Participants; Type 2 Diabetes

Summary: this phase i study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of azd5004 in both healthy japanese participants and japanese participants with t2dm.

this is a placebo-controlled study to assess the safety, efficacy, tolerability, and pk of single and repeated dosing of azd5004 compared with placebo. participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive azd5004 or matching placebo. the study will comprise: 1. a screening period of maximum 28 days. 2. a treatment period of 1 day(part a) or 105 days (part b). 3. a final follow-up visit approximately 7 days(part a) or 14 days(part b) after the last study intervention administration.

Eligibility criteria:
inclusion criteria: * japanese men or women, and 18-65 years of age inclusive, at the time of signing the informed consent. inclusion criteria for part a: * hba1c ≤ 6.0%. * body weight ≥ 50.0 kg and bmi within the range 18.0-32.0 kg/m2. inclusion criteria for part b: * hba1c ≥ 6.5% and ≤ 10.5%. * not on any other diabetic medications. * body weight ≥ 60.0 kg and bmi within the range 24.0-35.0 kg/m2 exclusion criteria: * has a clinically relevant acute or chronic medical condition or disease. * history of acute pancreatitis and chronic pancreatitis, gallstones. * abnormal renal function. * known clinically significant gastric emptying abnormality * significant hepatic disease. * uncontrolled thyroid disease

Keywords: obesity type 2 diabetes